This Week at FDA: User fee timeline, bivalent boosters, and more

This Week at FDAThis Week at FDA | 01 July 2022 |  By 

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. The biggest news out of FDA this week was the agency’s decision to recommend the inclusion of an Omicron BA.4/5 component in future booster doses in the first shift in strain composition away from monovalent vaccines targeting the prototype virus.
Alongside the recommendation, FDA released a memo explaining its rationale and the considerations that fed into its decision on the strain selection. The move followed a vote by FDA’s Vaccines and Related Biological Products Advisory Committee on Tuesday in support of including an Omicron component in modified boosters, though the committee was not asked to vote on specific subvariants or on whether the primary series of any vaccines should be updated to reflect a new strain. Just before FDA made the recommendation, the Department of Health and Human Services (HHS) announced it has agreed to buy 105 million doses of the Pfizer-BioNTech vaccine for adults and children for use in a fall vaccination campaign.
The timeline for Congress to reauthorize FDA’s user fee agreements is in danger of falling behind, Politico reports. If reauthorization bill is not signed by August, it could trigger the agency to send 60-day layoff notices to employees whose positions are funded via the programs.
We also learned from FDA Commissioner Robert Califf that the agency has filled two critical leadership positions. Califf tweeted that Dr. Namandjé N. Bumpus will be joining the agency as its Chief Scientist and Dr. Hilary D. Marston will serve as Chief Medical Officer.
Drugs & biologics
On Thursday, we learned that Pfizer has submitted a new drug application (NDA) to FDA for its COVID-19 antiviral drug Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets). The drug was the first oral treatment authorized by the agency for COVID-19 and has been available under emergency use authorization (EUA) since December 2021.
Speaking of COVID-19 products, FDA this week authorized dosing revisions for AstraZeneca’s COVID-19 antibody therapy Evusheld (tixagevimab co-packaged with cilgavimab). The revised fact sheet now recommends repeat dosing every six months with 300mg of tixagevimab and 300mg of cilgavimab, whereas previous instructions did not specify a dosing interval.
In a new safety communication issued on Thursday, FDA warned that cancer drug Copiktra (duvelisib) could increase the risk of death compared to another treatment for chronic leukemia and lymphoma.
FDA also finalized two guidances this week intended to guide the development of adjuvant treatments for renal cell carcinoma and bladder cancer. Both guidances were released in draft form in 2020.
We also learned that FDA’s upcoming draft guidance on dose banding based on weight or body surface area has reached the Office of Management and Budget for review, indicating that it could be released shortly.
Plus, we saw FDA issue a warning letter to Texas-based Re-Gen Active Lab for marketing multiple cell products for allogenic use without obtaining licensure or qualifying for any exceptions from licensure requirements as human cells, tissues, or cellular or tissue-based products (HCT/Ps).
Medical devices
Sens. Elizabeth Warren (D-MA) and Charles Grassley (R-IA) wrote to Califf this week to highlight what they say are efforts by the “dominant” hearing aid manufacturers to dampen the agency’s recently proposed rule to enable over-the-counter hearing aids. The lawmakers wrote that the manufacturers seek to “undermine the rule and diminish the effectiveness” of OTC hearing aids in comments to the proposed rule.
FDA also announced that it intends to reclassify optical diagnostic devices for melanoma detection and electrical impedance spectrometers from class III, which requires premarket approval, to class II (special controls). If reclassified, the devices would be subject to the less stringent premarket notification pathway.  


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